The invention concerns an apparatus for the determination of the release of active ingredients by soluble pharmaceutical products. These products may be in forms suitable for oral administration, in particular tablets, pills, capsules and beads. The inventive apparatus comprises a plurality of vessels located in a stand and equipped with a vertically-moving, centrally-driven agitator for each vessel. The apparatus also has means for filling and emptying the vessels of the appropriate liquids.
The testing for active ingredient release involves testing medicines under controlled and constant conditions. These conditions include the test temperature, agitator velocity, analysis intervals and other parameters. Such investigations are described and specified in national standards for Germany (DAB: Deutches Arzneibuch--German Pharmacopeia) and international specifications, for example the USP (US Pharmacopeia) and BP (British Pharmacopeia). Such tests are an important evaluation criterion during the development of these drugs in addition to ongoing quality control. At least six samples are to be investigated simultaneously under constant conditions. The number of samplings may range from one to more than twenty.
The determination of the release of active ingredients from solid and soluble pharmaceutical products is a particularly labor-intensive and time-consuming activity in pharma-analytical laboratories.
The test specifications cited above contain detailed descriptions of the apparatus to be used. The apparatus appearance, size, construction materials, agitator configuration, and tolerances to be observed in the essential components are all set forth.
Devices are known for making release rate determinations and which satisfy the aforementioned specifications. The active ingredient release apparatus PTW 12 S of the Pharmatest GmbH Co., D-6452 Hainburg is one such apparatus.
The Pharmatest PTW 12 S apparatus consists essentially of a row of vessels. Each vessel is equipped with a centrally-driven agitator. The vessels are essentially cylindrical and have a hemispherical bottom. Charging, sampling, and cleaning are effected manually from the open top of the cylinder. This manual operation is not efficient and leads to avoidable interferences. For example, the vessels are cleaned in succession. This sequence requires considerable time.